ArticleToxicological sciences : an official journal of the Society of Toxicology2022
Evaluation of Variability Across Rat Acute Oral Systemic Toxicity Studies.
Article in Toxicological sciences : an official journal of the Society of Toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
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The trial behind it
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Who cites it
25 citing papers in PubMed.
- AI/ML-based computational models for toxicity prediction.Environmental science and pollution research international · 2026Review
- Exploring the pharmacological potential of plant-based hand sanitizer composition: characterization, activity evaluation, and in silico assessment.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Perspectives on variability ofFrontiers in toxicology · 2026Article
- In vivo acute oral toxicity assessment of novel histone deacetylase 2 inhibitor.BMC pharmacology & toxicology · 2025Article
- Transferability and Reproducibility of the HepaRG CometChip Assay.Environmental and molecular mutagenesis · 2025Article
- Unveiling the potential anticancer activity of Spirulina maxima extract-nanoemulsion through in vitro and in vivo studies.Scientific reports · 2025Article
- HepaRGNAM journal · 2025Article
- Comparative case study on NAMs: towards enhancing specific target organ toxicity analysis.Archives of toxicology · 2024Article
- Enhancing Sustainable Analytical Chemistry in Liquid Chromatography: Guideline for Transferring Classical High-Performance Liquid Chromatography and Ultra-High-Pressure Liquid Chromatography Methods into Greener, Bluer, and Whiter Methods.Molecules (Basel, Switzerland) · 2024Review
- Evaluation of in silico model predictions for mammalian acute oral toxicity and regulatory application in pesticide hazard and risk assessment.Regulatory toxicology and pharmacology : RTP · 2024Article
- New approach methodologies (NAMs): identifying and overcoming hurdles to accelerated adoption.Toxicology research · 2024Review
- Artificial intelligence (AI)-it's the end of the tox as we know it (and I feel fine).Archives of toxicology · 2024Review
- Free and open-source QSAR-ready workflow for automated standardization of chemical structures in support of QSAR modeling.Journal of cheminformatics · 2024Article
- Article
- Novel Strategy to Assess the Neurotoxicity of Organic Solvents Such as Glycol Ethers: Protocol for Combining In Vitro and In Silico Methods With Human-Controlled Exposure Experiments.JMIR research protocols · 2024Article
- Reproducibility of organ-level effects in repeat dose animal studies.Computational toxicology (Amsterdam, Netherlands) · 2023Article
- New approach methodologies in human regulatory toxicology - Not if, but how and when!Environment international · 2023Review
- ChemMaps.com v2.0: exploring the environmental chemical universe.Nucleic acids research · 2023Article
- Article
- From vision toward best practices: EvaluatingFrontiers in toxicology · 2023Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
Regulatory agencies rely upon rodent in vivo acute oral toxicity data to determine hazard categorization, require appropriate precautionary labeling, and perform quantitative risk assessments. As the field of toxicology moves toward animal-free new approach methodologies (NAMs), there is a pressing need to develop a reliable, robust reference data set to characterize the reproducibility and inherent variability in the in vivo acute oral toxicity test method, which would serve to contextualize results and set expectations regarding NAM performance. Such a data set is also needed for training and evaluating computational models. To meet these needs, rat acute oral LD50 data from multiple databases were compiled, curated, and analyzed to characterize variability and reproducibility of results across a set of up to 2441 chemicals with multiple independent study records. Conditional probability analyses reveal that replicate studies only result in the same hazard categorization on average at 60% likelihood. Although we did not have sufficient study metadata to evaluate the impact of specific protocol components (eg, strain, age, or sex of rat, feed used, treatment vehicle, etc.), studies were assumed to follow standard test guidelines. We investigated, but could not attribute, various chemical properties as the sources of variability (ie, chemical structure, physiochemical properties, functional use). Thus, we conclude that inherent biological or protocol variability likely underlies the variance in the results. Based on the observed variability, we were able to quantify a margin of uncertainty of ±0.24 log10 (mg/kg) associated with discrete in vivo rat acute oral LD50 values.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.